Risk-Based Approach

There is no doubt software plays a critical role in modern production and operations processes. But despite its ubiquity, most systems must be uniquely designed or configured to meet the specific needs of a business. When deployed in a GMP environment, these unique characteristics can be a challenge to efficiently validate for FDA-compliance. How much validation is enough? How much is too much?

Since one size doesn't fit all when it comes to evaluating complex operational compliance issues, we employ a risk-based approach that tailors validation efforts not only to the specifics of your business, but also to the level of risk each component represents to conformity efforts and ramifications.

The overall risk posed by software is generally considered to be a function of system complexity, patient/product impact, and pedigree (Configurable-Off-The-Shelf or Custom-written for a certain purpose). A lower risk system typically merits a less in-depth specification/testing/validation approach.

This risk based approach maximizes the value of FDA mandated computer system validation by identifying critical steps and functions, focusing tests on what really matters to your process while drawing on well-established industry standards. We will work with you on qualification and validation services to define the scope of your testing and compliance needs, and establish clear system boundaries. Given the high cost of software, hardware and deployment, we work with you to ensure that you are minimizing the time and money needed to complete any given validation project.